FDA WARNING_LETTER - Desert Star Dairy - March 09, 2012

On March 5-9, 2012, the FDA inspected Desert Star Dairy, LLC, finding multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on November 7, 2011, was found to have 0.12 ppm Sulfadimethoxine in its liver, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including failure to maintain an adequate system for withholding medicated animals from slaughter for appropriate withdrawal periods and incomplete treatment records for medicated animals sold for food. These conditions cause food to be adulterated under 21 U.S.C. § 342(a)(4).

Furthermore, the dairy adulterated Sulfadimethoxine by using it extralabelly without a licensed veterinarian's supervision, specifically administering it to a dairy cow without following approved dosage and duration. This violated 21 CFR 530.11(a) and resulted in an illegal drug residue, violating 21 CFR 530.11(d), making the drug unsafe and adulterated under 21 U.S.C. § 351(a)(5).

The FDA acknowledged an inadequate response to the Form FDA 483 and requires Desert Star